Rule2022-18990
Possession, Use, and Transfer of Select Agents and Toxins; Regulation of an Attenuated Vaccine Strain of Venezuelan Equine Encephalitis Virus as a Select Agent
Primary source
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Published
September 1, 2022
Effective
September 1, 2022
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are notifying the public that the Animal and Plant Health Inspection Service (APHIS) has determined that the modified Venezuelan equine encephalitis virus (VEEV) strain TC-83(A3G), which is a modification to the attenuated strain VEEV TC-83, has demonstrated increased pathogenicity and lethality and that the strain has the potential to pose a severe threat to animal health or animal products. We are advising the public that VEEV strain TC-83(A3G) is therefore a select agent and subject to APHIS' select agent and toxin regulations.
Full Text
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[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Page 53647]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18990]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 /
Rules and Regulations
[[Page 53647]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 121
[Docket No. APHIS-2022-0034]
Possession, Use, and Transfer of Select Agents and Toxins;
Regulation of an Attenuated Vaccine Strain of Venezuelan Equine
Encephalitis Virus as a Select Agent
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Regulatory determination.
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SUMMARY: We are notifying the public that the Animal and Plant Health
Inspection Service (APHIS) has determined that the modified Venezuelan
equine encephalitis virus (VEEV) strain TC-83(A3G), which is a
modification to the attenuated strain VEEV TC-83, has demonstrated
increased pathogenicity and lethality and that the strain has the
potential to pose a severe threat to animal health or animal products.
We are advising the public that VEEV strain TC-83(A3G) is therefore a
select agent and subject to APHIS' select agent and toxin regulations.
DATES: Effective September 1, 2022.
FOR FURTHER INFORMATION CONTACT: Dr. Randy Capsel, Science Officer,
Division of Agricultural Select Agents and Toxins, Emergency and
Regulatory Compliance Services, Animal and Plant Health Inspection
Service, 4700 River Road, Riverdale, MD 20737; Telephone: (301) 851-
3402; email: <a href="/cdn-cgi/l/email-protection#f2a0939c968bdca6dcb1938281979eb287819693dc959d84"><span class="__cf_email__" data-cfemail="92c0f3fcf6ebbcc6bcd1f3e2e1f7fed2e7e1f6f3bcf5fde4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
The Agricultural Bioterrorism Protection Act of 2002, as amended
(the Act, 7 U.S.C. 8401) provides for the regulation of certain
biological agents and toxins that have the potential to pose a severe
threat to animal and plant health, or to animal and plant products. The
Animal and Plant Health Inspection Service (APHIS) has the primary
responsibility for implementing the provisions of the Act within the
U.S. Department of Agriculture. The Act also provides authority for
APHIS to jointly regulate with the U.S. Department of Health & Human
Services' Centers for Disease Control and Prevention (CDC) biological
agents and toxins that have the potential to pose a serve threat to
both public health and safety and animal health or animal products.
The regulations in 9 CFR part 121 (referred to below as the
regulations) implement the provisions of the Act by setting forth the
requirements for possession, use, and transfer of Veterinary Services
select agents and toxins. In Sec. 121.4 of the regulations, paragraph
(e) sets forth a process by which an attenuated strain of a select
agent or toxin modified to be less potent or toxic may be excluded from
the requirements of the select agent and toxin regulations in part 121
based upon a determination by APHIS' Administrator that the attenuated
strain or modified toxin does not pose a severe threat to public health
and safety, animal health, or animal products. Under Sec. 121.4(e)(2),
if an excluded attenuated strain is subjected to any manipulation that
restores or enhances its virulence, resulting in a select agent that
poses a severe threat to animal health or animal products, the
resulting select agent will be subject to the requirements of the
regulations in part 121.
Venezuelan equine encephalitis virus (VEEV) is a member of the
genus Alphavirus in the family Togaviridae, and is a small, enveloped
virus with a genome consisting of a single strand of positive-sense
RNA. VEEV is a mosquito-borne virus that causes encephalitis or
encephalomyelitis in all equine species and humans. Because it can
affect both animals and humans, VEEV is listed as an overlap select
agent in Sec. 121.4(b) of the regulations and therefore is subject to
regulation by both APHIS and CDC. On February 7, 2003, VEEV strain TC-
83 was excluded from the regulations because mice vaccinated
subcutaneously with VEEV strain TC-83 rapidly developed immunity to
subcutaneous or airborne challenge with virulent VEEV.\1\ Based on
these findings, APHIS, in collaboration with CDC, determined that the
attenuated strain did not have the potential to pose a severe threat to
animal health or animal products.
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\1\ See <a href="https://www.selectagents.gov/sat/exclusions/overlap.htm">https://www.selectagents.gov/sat/exclusions/overlap.htm</a>.
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However, based on a recent review by subject matter experts, APHIS
has determined that a modification to the excluded, attenuated VEEV
vaccine strain TC-83 has been shown to increase its virulence and
pathogenicity. An adenine (A) at position 3 in TC-83 has been shown to
contribute to the attenuation of VEEV. In TC-83(A3G), the A has been
changed to a guanine (G), which is found in all wild-type isolates of
VEEV. The reversion of this nucleotide mutation to the wild-type
nucleotide resulted in increased lethality in mice when compared to
mice inoculated with the vaccine strain TC-83. Additional data
determined that the pathogenic effects of TC-83(A3G) are more
pronounced in young mice.
As a result, the modification of the excluded, attenuated VEEV
vaccine strain TC-83 to create VEEV strain TC-83(A3G) restores the
virus's virulence and has the potential to pose severe threat to animal
health or animal products. Therefore, VEEV strain TC-83(A3G) is subject
to the regulations in part 121.
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 29th day of August 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-18990 Filed 8-30-22; 11:15 am]
BILLING CODE 3410-34-P
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